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510(k) Data Aggregation

    K Number
    K241490
    Device Name
    Contour+ (MVision AI Segmentation)
    Manufacturer
    MVision AI Oy
    Date Cleared
    2024-10-18

    (147 days)

    Product Code
    QKB
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MVision AI Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Contour+ (MVision Al Segmentation) is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT and MR images using machine learning based algorithms. The produced segmentation templates for regions of interest must be transferred to appropriate image visualization systems as an initial template for a medical professional to visualize, review, modify and approve prior to further use in clinical workflows. The system creates initial contours of pre-defined structures of common anatomical sites, i.e., Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis. Contour+ (MVision Al Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.
    Device Description
    Contour+ (MVision Al Segmentation) is a software-only medical device (software system) that can be used to accelerate region of interest (ROI) delineation in radiotherapy treatment planning by automatic contouring of predefined ROIs and the creation of segmentation templates on CT and MR images. The Contour+ (MVision Al Segmentation) software system is integrated with a customer IT network and configured to receive DICOM CT and MR images, e.g., from a CT or MRI scanner or a treatment planning system (TPS). Automatic contouring of predefined ROIs is performed by pre-trained, locked, and static models that are based on machine learning using deep artificial neural networks. The models have been trained on several anatomical sites, including the brain, head and neck, bones, breast, lung and abdomen, male pelvis, and female pelvis using hundreds of scans from a diverse patient population. The user does not have to provide any contouring atlases. The resulting segmentation structure set is connected to the original DICOM images and can be transferred to an image visualization system (e.g., a TPS) as an initial template for a medical professional to visualize, modify and approve prior to further use in clinical workflows.
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